My Article - Rotavirus Vaccine: Diarrhoea of Deceit

Rotavirus Vaccine: Diarrhea of Deceit

The rotavirus vaccine is a textbook example of what’s wrong with the vaccine industry. It works for only a limited number of rotavirus types, causes severe adverse effects including death, was approved via corrupt agencies & officials with financial ties to the manufacturer—and it results in far more cases of a far more deadly disease.

Photo of man in jeans (original knives replaced by hypodermics) by David Goehring

by Jagannath Chatterjee

When doctors prescribe the Rotavirus vaccine as a preventive against diarrhea, the deception begins. Parents are not informed that diarrhea can be caused by a host of factors, including bacterial and viral infections. Bacterial infections resulting from unclean water are more harmful. Viral infections leading to diarrhea do not pose any danger if the child is treated with an oral rehydration solution or is breastfed, which can prevent dehydration.

There are many strains of rotavirus and most are yet to be identified. Besides the rotavirus strains, diarrhea can also be caused by astroviruses, calciviruses, other pathogens, and toxins. The rotavirus vaccine, delivered orally, contains just four of the many rotavirus strains and can protect against only these strains, leaving the child unprotected against the major factors.

The first rotavirus vaccine was licensed in the USA in 1998 and was recommended in March 1999. Parents did not know that this vaccine was recommended by ignoring serious side effects noticed in clinical trials. As a result many children suffered inversion of part of the intestine into an adjacent section—a condition called intussusception—a very serious, painful, and often fatal condition. Deaths for unexplained reasons were reported. Consequently the vaccine was withdrawn in October 1999.

When the US Congress investigated, serious procedural problems and negligence came to the fore, prompting a hearing on June 15, 2000. It revealed that both the FDA and CDC, US regulatory bodies, were aware about the vaccine’s serious adverse effects. There was also conflict of interest as two members on the advisory committee profited from the decision. Dr. Kathryn Edwards had received research funds worth $255,000 per year from the vaccine manufacturer. Dr. Paul Offit held a patent on another rotavirus vaccine and his travel around the country to advise about vaccine safety was funded by vaccine manufacturers. Moreover, 60% of FDA advisory committee members and 50% of CDC members had financial ties with the manufacturers of the vaccine. Clearly, the greed of both officials and the pharmaceutical industry prompted the flouting of all rules and the health of children took second place.

One
had expected serious action on the basis of the findings but nothing happened.
The erring agencies, who ought to maintain very high standards of honesty and
integrity, instead justified that there was no bar that officials with ties to
the industry could not recommend vaccines. In 2006 two other versions of the
vaccine, containing live viruses and orally administered, were out in the
market, recommended by those very tainted officials and doctors.

A
peep into the clinical trials revealed alarming facts. The vaccine had not been
compared to an inert placebo but against the same vaccine with all the
ingredients minus the virus so that it could be declared safer than it was. The
viruses used were an assortment of human and cow viruses propagated in cells of
African green monkeys, the same specimen that has resulted in the OPV being
contaminated with monkey viruses. The cells are kept alive in a cow serum
medium which further opens the door to unknown viruses. The chemical
ingredients of the vaccine contain Polysorbate 80, a known reproductive toxin.

The
clinical trials have recorded a lower incidence of intestinal blockage, signifying
that even the new vaccine is not free from the controversy. The vaccinated
children have a three times greater risk of suffering from intestinal bleeding,
even after accounting for many cases that were denied by the supervising team.
The trials revealed gangrene and necrosis of the intestines, severe vomiting
leading to hospitalization, seizures caused by abnormal electrical discharges
in the brain that in some cases became chronic, eczema, diarrhoea (the very
disease the vaccine is supposed to prevent), frequent ear infections,
difficulty in breathing, asthma, and nasopharyngitis which is a viral
infectious disease of the upper respiratory tract.

Recent
media reports have noted that the use of this vaccine in the USA has caused an
alarming increase in cases of a far more lethal noravirus infection which is
causing 21 million cases and 800 deaths annually against the 20 to 40 annual
deaths that occur from rotavirus infections. There has also been a dramatic
increase in cases of inflammatory bowel disease. Instead of reviewing the situation and
withdrawing the rotavirus vaccine, which has caused the shift to a more lethal
virus, a vaccine for noravirus has been developed and is ready for marketing.

Alarmed
by the adverse effects of the vaccine in India and noting that rotavirus
related diarrhoea is easily treated without complications, and the rates for
India are based upon estimates kept high to alarm the public, ethical doctors
in India pointed out that the high cost of the vaccine makes it prohibitive and
not cost effective in India. A study has revealed that the incidence of
diarrhoea and related deaths in India is directly related to poverty, lack of
clean drinking water, and sanitation and that in most cases it requires the
presence of other pathogens for rotavirus to cause diarrhoea.

Doctors
trying to report cases of adverse effects have been stopped from doing so by
the Indian Academy of Paediatrics (IAP) - an agency which is entirely dependent
on funds from vaccine manufacturers for its operations – under the plea that
the safety profile of the vaccine should not be tarnished as the IAP is
lobbying for its inclusion in the government programme.

Recently,
to counter the cost effectiveness argument, Indian scientists provided great
publicity to an indigenously prepared and low priced rotavirus vaccine. Even as
the publicity, backed by the Department of Biotechnology in India, was picked
up by the national and international press, it emerged that the results of the
clinical trials are yet to be made public. It has also been pointed out that
the vaccine has only one rotavirus strain, and has been tested on 4,532 infants
whereas to fully determine the adverse events it needs to be tested on more
than 50,000. Incidentally the Indian vaccine requires that mothers should stop
breastfeeding their children during its period of administration and working –
a highly controversial aspect.

Providing
publicity to clinical trial findings before the results are published is a
violation of medical ethics. This would make it difficult for a peer reviewed
journal to publish the findings. The involvement of controversial agencies like
PATH and BMGF in the evolution of this vaccine which had in the recent past,
with the active connivance of government agencies in India, illegally tested
the highly controversial and unsafe cervical cancer vaccine on tribal girls in
Andhra Pradesh and Gujarat without parental consent resulting in several deaths
and adverse effects has also riled the health activists.

Under
these conditions it remains to be seen whether the industry backed attempt to mass
administer a questionable and unsafe corporate product to tackle diarrhoea will
succeed and take preference over genuine public health needs like eradication
of poverty, provision for clean water and sanitation, and nutrition for the
mother and child. Now the ball is in the court of the Government of India,
which sadly has a tainted record for allowing the administration of the OPV
which has caused paralysis cases in the country to soar from 3000 cases to
60,000 annually, and is now claiming credit for a “polio free” India.